Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

SB65-401.1 — Class IIa MDD by newbox medical GmbH

MD Atlas
newbox medical GmbH

EUDAMED last updated this device on Apr 15, 2026

SB65-401.1

B-04059216168178

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: newbox medical GmbH
UDI-DI code: 04059216168178
Reference / catalog number: SB65-401.1

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: newbox medical GmbH
SRN: DE-MF-000020279
Manufacturer status: Active

Related devices

SB52-402B-04059216079757On the market SB 60-332B-04059216082139On the market SB 60-332.1B-04059216166396On the market SB30-201B-04059216079160On the market SB30-201.1B-04059216163425On the market

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 30, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04059216168178
Basic UDI-DI: B-04059216168178
Reference / catalog number: SB65-401.1
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: SB65-401.1
Additional information URL: https://www.newbox-medical.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L1999ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

MDR-0019Amended
Quality management systemNotified body: 1304Expiry: Oct 15, 2029